PDA Journal of Pharmaceutical Science and Technology最新文献_第6页

Insights for the Use of Enzyme Indicators in Hydrogen Peroxide Bio-Decontamination Cycle Validation. 酶指标在双氧水生物去污循环验证中的应用。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2025-000054.1

K Gabbott, E Bertin, C Dew, R Panton, C R Rosenvang

{"title":"Insights for the Use of Enzyme Indicators in Hydrogen Peroxide Bio-Decontamination Cycle Validation.","authors":"K Gabbott, E Bertin, C Dew, R Panton, C R Rosenvang","doi":"10.5731/pdajpst.2025-000054.1","DOIUrl":"10.5731/pdajpst.2025-000054.1","url":null,"abstract":"Enzyme Indicators (EIs) are strips of purified thermostable adenylate kinase (tAK) that are currently used across the world in the pharmaceutical industry to quantitatively assess the bio-decontamination efficacy of hydrogen peroxide (H2O2). Adoption of EIs in the hydrogen peroxide bio-decontamination cycle validation has increased across the pharmaceutical industry because of the numerous advantages they have over current assessment tools such as biological indicators (BIs). These benefits include a rapid result, reduced variation, and simplified handling due to the reduced contamination risk incurred from not using viable organisms. A number of pharmaceutical industry validation teams who have successfully integrated EI technology into their validation strategy realized that it would be advantageous to have an EI industry working group to look together at the adoption of the technology and bring a standardization of the validation approach. This paper provides a comprehensive approach to analyzing and applying EI use following the extensive compilation of data and methods from leading global pharmaceutical companies, including the points that are to be considered for handling, use, and data analysis of EIs within the steps of bio-decontamination validation.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"405-421"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148144305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Enhancing Confidence in Cleanroom Air Sampling Validation by Bridging ISO Standards with the ARMM Framework: Poster Presented at PDA Week 2026. 通过将ISO标准与ARMM框架连接起来，增强对洁净室空气采样验证的信心：2026年PDA周上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26413

Corina Keller

{"title":"Enhancing Confidence in Cleanroom Air Sampling Validation by Bridging ISO Standards with the ARMM Framework: Poster Presented at PDA Week 2026.","authors":"Corina Keller","doi":"10.5731/pdajpst.2026.26413","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26413","url":null,"abstract":"Reliable monitoring of airborne microbial contamination is critical for maintaining GMP-compliant cleanroom environments in pharmaceutical manufacturing. While EN ISO 14698 and EN 17141 provide the regulatory framework for validating the physical and biological performance of portable air samplers, they may not fully reflect real-world production conditions or ensure methodological robustness.To strengthen validation confidence, we incorporated criteria from Alternative or Rapid Microbiological Methods (ARMM)-including ruggedness, robustness, equivalence, and specificity as outlined in Ph. Eur. 5.1.6, USP < 1223>, and PDA Technical Report 33-into the conventional ISO-based validation of a portable air sampler. This integrative approach enables a more practical assessment of sampler performance under actual cleanroom conditions.In collaboration with Hoffmann-La Roche AG, we applied this methodology to a portable air sampler in a real-world cleanroom setting.The study demonstrates how ARMM criteria can enhance the reliability of microbial monitoring and support robust cleanroom validation strategies.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"486-487"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Revolutionizing Vial Surface Chemistry to Enhance Lyophilization Success: Poster Presented at PDA Week 2026. 革命性的瓶表面化学，以提高冻干的成功：海报呈现在PDA周2026。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26430

Diane M McCormick, Evgeniia Vorozhbit, Steve Nail, Alina Alexeenko

引用次数: 0

Inner Diameter of Hypodermic Needles: A Critical Factor in Prefilled Syringe Design. 皮下注射针的内径：预充式注射器设计的关键因素。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026-000002.1

Remo Eugster, Cormac McCrea, Simon Knappke, Saskia Schmidt, Alexander Zuern, Oliver Germershaus

{"title":"Inner Diameter of Hypodermic Needles: A Critical Factor in Prefilled Syringe Design.","authors":"Remo Eugster, Cormac McCrea, Simon Knappke, Saskia Schmidt, Alexander Zuern, Oliver Germershaus","doi":"10.5731/pdajpst.2026-000002.1","DOIUrl":"10.5731/pdajpst.2026-000002.1","url":null,"abstract":"In the frame of pharmaceutical device development, the evaluation of component properties and their effects on overall device performance characteristics poses a substantial challenge. The hydrodynamic inner diameter (IDh) of a staked-in needle prefilled syringe (PFS) represents such a parameter affecting device performance, especially in the case of autoinjectors, where injection times can vary by up to 30% depending on the IDh Herein, measurement systems to detect variation of IDh in sampling-based, AQL-driven incoming goods control were evaluated. To ensure the capability of such fluid-based IDh measurement systems, measurement system analysis studies combined with µ-computer tomography of reference samples were applied. A round-robin study assessing different IDh measurement methods was performed, identifying the semi-automated measurement system as suited for reliable and accurate measurement. A second study examined possible variations between PFS batches and different manufacturers regarding the IDh The study revealed statistically significant variation of IDh ranging from 259 to 300 µm for 27 G special thin wall needles. For auto injectors, lack of proper control of IDh might lead to more variable injection time and even device stalling. This may ultimately result in an unsatisfactory patient experience and incomplete dosing. Hence, control over needle parameters can have a beneficial impact on patient experience and ultimately on treatment success.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"446-463"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148423113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development of a User Requirement Specification (URS) for a Biofluorescent Particle Counter (BFPC) for Surface and Personnel Monitoring in Aseptic Processing Areas: Poster Presented at PDA Week 2026. 用于无菌处理区域表面和人员监测的生物荧光粒子计数器（BFPC）的用户需求规范（URS）的开发：在PDA周2026上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26412

Philip Villari, Vanessa Figueroa, Allison Scott, Michael Dingle, Tony Cundell, Petra Merker

{"title":"Development of a User Requirement Specification (URS) for a Biofluorescent Particle Counter (BFPC) for Surface and Personnel Monitoring in Aseptic Processing Areas: Poster Presented at PDA Week 2026.","authors":"Philip Villari, Vanessa Figueroa, Allison Scott, Michael Dingle, Tony Cundell, Petra Merker","doi":"10.5731/pdajpst.2026.26412","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26412","url":null,"abstract":"Pharmaceutical manufacturers are implementing BFPC technology for in-process monitoring and control of unidirectional air flow in aseptic filling operations to improve cleanroom operations, thus enhancing sterility assurance and product quality. Continuous real-time monitoring is able to reduce the industry's reliance of growth-based methods for 5 to 7-day incubation periods to obtain results. A similar approach to surface and personnel monitoring is necessary to complete the environmental monitoring review for GMP batch release without the delay due to the traditional methods.This poster will offer an overview of what the M3 collaboration expects the vendor community to include when developing instrumentation for BFPC surface monitoring as part of the User Requirement Specification (URS). Key elements include the rationale for development, device description, business case, validation and calibration parameters, and desirable features.A major consideration is the ability to count Auto-fluorescent Units (AFU) per 25 cm2 on both flat facility surfaces and irregular ones (for example, needles, stopper tracks, stopper insertion pistons). This may require two sampling devices rather than one. The aim of our initiative is to streamline the development of a BFPC surface monitoring system; feedback on the value of the proposed URS will be gathered during the poster session.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"484-485"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Designing a CCS That Focuses on Materials Transfer into Cleanrooms, BSCs, RABS, and Isolators: Poster Presented at PDA Week 2026. 设计一个专注于材料转移到洁净室，BSCs， RABS和隔离器的CCS: 2026年PDA周的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26411

James N Polarine, Mary Van Gaasbeck Carico, Renee Buthe

引用次数: 0

Bridging the Gap: Mitigating a Hidden Cleaning Risk in Large-Scale Freeze-Thaw Unit Commissioning: Poster Presented at PDA Week 2026. 弥合差距：减少大型冻融装置调试中隐藏的清洁风险：PDA周2026上的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26407

Briana Nicole, Fabian Plaum

{"title":"Bridging the Gap: Mitigating a Hidden Cleaning Risk in Large-Scale Freeze-Thaw Unit Commissioning: Poster Presented at PDA Week 2026.","authors":"Briana Nicole, Fabian Plaum","doi":"10.5731/pdajpst.2026.26407","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26407","url":null,"abstract":"During the commissioning and qualification (C&Q) of a new large-scale freeze-thaw unit in a GMP manufacturing environment, a significant cleaning concern was identified involving the bottom shelf assembly. A non-fixed Teflon plate, intended as an insulation layer between the lower shelf and the pressure table, creates a narrow gap prone to fluid accumulation. This area is inaccessible for standard manual cleaning, posing a microbial and cross-contamination risk.The Teflon plate provides an insulation layer between the lower shelf and the pressure table. The current removal process is labor-intensive, requiring a two-person lift to clear internal pins, which introduces ergonomic risks and potential mechanical strain on critical hose connections. To resolve this, we collaborated with the vendor on a design evolution. This presentation details the investigative approach used to identify this \"hidden\" risk and the subsequent collaboration with the equipment vendor to re-engineer the pin design. Reducing pin length enables horizontal plate removal without lifting the shelf assembly, which successfully bridges the gap between mechanical requirements and GMP cleanability.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"474-475"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

PUPSIT Simulation as part of Process-Specific Bacterial Retention Testing (PUPSIT-BCT): Poster Presented at PDA Week 2026. 作为工艺特异性细菌保留测试（PUPSIT- bct）的一部分的PUPSIT模拟：在PDA周2026上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26426

Yvonne Groß, Mariam Salamatian

{"title":"PUPSIT Simulation as part of Process-Specific Bacterial Retention Testing (PUPSIT-BCT): Poster Presented at PDA Week 2026.","authors":"Yvonne Groß, Mariam Salamatian","doi":"10.5731/pdajpst.2026.26426","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26426","url":null,"abstract":"Pre-Use Post Sterilization Integrity Testing is implemented in sterile filtration applications by drug manufacturers using a risk-based approach with consideration of the stipulation in Eudralex volume 4, Annex 1, of the European Union Good Manufacturing Practice for Sterile Products. During process-specific bacterial retention testing, required as part of sterile filter validation, it is important to simulate the filtration process under evaluation as closely as possible. Worst-case conditions experienced by the process filter during routine use that may impact the process filters' ability to produce a sterile effluent must be accounted for. Given these two facts, do PUPSIT conditions need to be considered during process-specific bacterial retention testing? And if so, how should they be simulated?Performing pre-use post sterilization integrity testing introduces additional mechanical stress on the process filter and a potential new route for the introduction of bioburden into the process fluid flow path related to the filter wetting procedure. We would like to present a risk-based bacterial retention test design that incorporates a pre-use post sterilization integrity testing simulation phase, after a thorough evaluation of the process specific conditions, to rule out impact on efficacy of the sterile filtration process.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"504-505"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Microbes Can Swim, but They Can't Hide: The Detection of a Range of Microorganisms Using an Online Water Bioburden Analyzer: Poster Presented at PDA Week 2026. 微生物可以游泳，但它们不能隐藏：使用在线水生物负荷分析仪检测一系列微生物：在PDA周2026上展示的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26424

Amanda Picazzo, Kim Perkins, Deja Van Vliet

引用次数: 0

Building Tomorrow's Biomanufacturing Workforce: A Dual Framework for Internal Development and External Partnerships: Poster Presented at PDA Week 2026. 建设明天的生物制造劳动力：内部发展和外部合作伙伴关系的双重框架：海报在PDA周2026。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26408

Adam P Snider

{"title":"Building Tomorrow's Biomanufacturing Workforce: A Dual Framework for Internal Development and External Partnerships: Poster Presented at PDA Week 2026.","authors":"Adam P Snider","doi":"10.5731/pdajpst.2026.26408","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26408","url":null,"abstract":"Developing a skilled workforce pipeline is crucial to scaling operations and ensuring the highest standards of quality and safety. To address this challenge, we propose a dual framework that incorporates both internal employee training to maximize personnel resources, as well as external outreach and workforce development programs.Our Spokane manufacturing site undertook a major workforce transformation by adopting a shared resource model and cross-training existing team members to perform multiple roles. This initiative enabled continuous 24-hour operations, improved flexibility, and allowed for more efficient deployment of technicians across production lines in preparation to scale operations.In addition to internal development, we collaborate with local academic institutions and economic development organizations to drive interest in biomanufacturing careers. Most notability, our investment in future talent through a partnership with the local community college to create a biotech manufacturing certification course prepares potential workforce members with the foundational skills needed to succeed in the growing pharma manufacturing industry.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"476-477"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0